NCT03953144RecruitingPhase 1/2
Synapse 3D With Intravascular Indocyanine Green
Synapse 3D With Intravascular Indocyanine Green Fluorescence Mapping for Targeted Pulmonary Segmental Resection Trial: A Phase I Safety and Feasibility Trial
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Synapse 3D) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Synapse 3D-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 30 Apr 2019
- Start date
- 1 Dec 2022
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Diseases
- Lung cancer
- NCT number
- NCT03953144
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- From 1 Dec 2022 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women who are currently pregnant or breastfeeding; or women of childbearing potential who are not currently taking adequate birth control.
Other illness
- Patients with clinical evidence of N1 or N2 disease on preoperative imaging
Lab values
- Hypersensitivity or allergy to ICG, sodium iodide, or iodine
Other
- Pulmonary Function tests demonstrating Forced Expiratory Volume in 1s (FEV1) or diffusion capacity of the lung for carbon monoxide (DLCO) less than or equal to 30% of predicted.
Who the study is looking for
- Tumour size \<3 cm
- Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
- CT-imaging confirming that the tumour is confined to one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Josephs Healthcare Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.